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Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00463060
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Max Sung, Icahn School of Medicine at Mount Sinai

Brief Summary:

Cancer is the second leading cause of death in the United States, with approximately 90% of deaths resulting from patients with metastatic spread. Save for notable exceptions such as testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients with limited metastatic deposits (most commonly colon cancer spread to the liver) can be cured with surgery followed by chemotherapy. Therefore, some patients with metastases should be considered for aggressive local therapy (surgery and/or radiation).

Even though chemotherapy has improved significantly, patients treated with conventional chemotherapy and/or biologically targeted therapy are not cured of their disease. For the most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy have major limitations preventing cure of these patients.

Radiation therapy is an effective modality of treating cancer. Until recently, radiation for metastases was used only to relieve symptoms resulting from local tumor growth. Technological advances, including stereotactic radiotherapy, allow for radiation to be more precisely delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that targets tumor blood vessels. It is effective against two types of cancer that rarely respond to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to determine if this is a safe regimen and the best method of combining these treatments. Ultimately, our goal is to cure some patients with previously incurable metastatic cancer with this combination.


Condition or disease Intervention/treatment Phase
Cancer Drug: sunitinib malate (Sutent) Procedure: radiotherapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Stereotactic Radiation Therapy and Concurrent and Adjuvant Sutent (SU11248) as Treatment for Oligometastatic Disease
Study Start Date : January 2007
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Participants treated with chemotherapy and radiotherapy
Drug: sunitinib malate (Sutent)
Sutent administered PO QD from days 1 to 28 Two weeks after completion of any chemotherapy, maintenance Sutent in 6 week cycles (consisting of Sutent 50 mg PO QD weeks 1-4 followed by no treatment weeks 5-6) until progression or death If no chemotherapy is planned, maintenance Sutent (as described above) will start on day 43.
Other Names:
  • sunitinib malate
  • Sutent

Procedure: radiotherapy
Radiation is to be delivered to each site over 10 fractions separated by at least 16 hours. Up to 5 sites may be treated
Other Name: XRT




Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: 2 years ]
    Sunitinib (SU) and radiation (IGRT) doses were sequentially escalated using a ping-pong strategy according to a 3 + 3 design phase 1 study. The starting dose was sunitinib 25 mg and IGRT 40 Gy. MTD reflects the highest dose that did not cause a dose limiting toxicity. Toxicity was in assessed in patients at regular intervals by using the Common Terminology Criteria for Adverse Events criteria (version 3.0). Dose limiting events were defined as any grade 4 or 5 toxicity and unexpected grade 3 toxicity. Expected grade 3 toxicities from radiation include mucositis or esophagitis lasting ≤7 days. Grade 3 metabolic and hematologic toxicities are considered expected events with sunitinib and therefore were not considered DLTs

  2. Number of Participants With Particular Disease Status [ Time Frame: 5 years ]
    Number of participants who have no evidence of disease and number of participants with distant metastases.


Secondary Outcome Measures :
  1. Percentage of Patients With Toxicity Grade 3 or Higher [ Time Frame: 5 years ]
    % of patients experienced one or more grade ≥ 3 toxicities. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4),and death (Grade 5).

  2. Percentage of Patients With Local Control [ Time Frame: 4 years ]
    Local control was defined as a tumor volume equal to or less than the tumor volume at start of radiotherapy.

  3. Percentage of Patients With Distant Control [ Time Frame: 4 weeks ]
    Distant control defined as distant metastasis contained outside of the radiation field within months of treatment.

  4. Quality of Life [ Time Frame: 4-6 weeks after radiation therapy ]
  5. Number of Participants According Failure and Survival [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Zubrod Performance Scale 0-1
  • Metastatic disease confirmed by biopsy or imaging
  • 5 or fewer sites of metastatic disease on tumor staging (either CT chest/abdomen/pelvis plus bone scan or whole body FDG-PET)
  • All tumors measure < 6 cm
  • Age > 18
  • Chemotherapy must be completed at least 2 weeks prior to radiation
  • Signed informed consent
  • Adequate bone marrow function, defined as follows;

    1. Platelets > 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
    2. Absolute neutrophil count (ANC) > 1,800 cells/mm3 based on CBC/differential obtained within 2 weeks prior to registration on study
    3. Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dt is acceptable.)

Exclusion Criteria:

  • Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical carcinoma in situ, and other treated malignancies with no evidence of disease for at least 3 years
  • Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
  • Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
  • Patients with exudative, bloody, or cytologically malignant effusions are not eligible.
  • Pregnancy or breast feeding (Women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
  • Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
  • Prior radiation to target area
  • Patient may not be receiving any other investigational agents during radiotherapy.
  • Prior history of non-inducible bleeding (12/16/09).
  • Requirement for continuation of anticoagulation (defined as Coumadin, lovenox, heparin, plavix, aspirin, NSAIDs or similar drugs) during treatment (12/16/09)
  • Under 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463060


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Pfizer
Investigators
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Principal Investigator: Max Sung, MD Icahn School of Medicine at Mount Sinai
Publications of Results:
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Responsible Party: Max Sung, MD, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00463060    
Other Study ID Numbers: GCO 06-0906
First Posted: April 19, 2007    Key Record Dates
Results First Posted: July 18, 2018
Last Update Posted: July 18, 2018
Last Verified: June 2018
Keywords provided by Max Sung, Icahn School of Medicine at Mount Sinai:
erlotinib
celecoxib
radiation
progression-free survival
Additional relevant MeSH terms:
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Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action